Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
Recruiting now
Conditions studied: Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Cancer, Cardiovascular Disease Risk
In brief
The goal of this clinical investigation is to explore a non-invasive technology for measuring the microcirculatory structure, composition and function in patients from a primary care population. The main aims are: 1. To evaluate the robustness of the technology for assessment of the molecular composition and structure of the skin tissue and microcirculatory function, on a prospective primary care population. 2. To evaluate the device and method on its capability to detect deficiencies in circulation, compared with existing reference systems with similar characteristics for patients with known cardiovascular disease risk and/or diabetes.
Key facts
- Study ID
- NCT06976073
- Run by
- HJN Sverige AB/Neko Health
- People needed
- 8000
- Starts
- 2023-02-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-05-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult patients part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation.
- Patients with signed informed consent
You may not qualify if…
- Cognitive impairment
- Patients unable to understand the oral and written study information in Swedish or English
- Other severe disorder or terminal disease
- Patients unable to provide an informed consent
- Patient´s with damaged, scarred or non-intact skin within the skin area of interest.
Where it is running
- Atrium Health Care Centre — Stockholm, Sweden (enrolling)
- Neko Health Centre, Regeringsgatan — Stockholm, Sweden (enrolling)
- Neko Health Centre, Sibyllegatan — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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